The Regulatory Assistant will support on preparing document for all applications with all Thai regulatory agencies as well as handle all related regulatory documents for compliance as assigned.
This role will also coordinate with external organizations including laboratory, accredited certification body, and other government agencies in order to complete tasks according to legislation’s requirements.
The Regulatory Assistant is also responsible for driving all compliance issues such as labelling compliance and renewal company’s licenses; as well as supporting customer’s inquiry such as product review, usage limit and regulatory compliance statement.
Regulatory Assistant Manager
- Prepare all related regulatory documents for compliance as assigned i.e. new product registration, amendment license and label, adding new food storage location, amendment machinery and site layout as well as support Taiwan registration for Thai made product
- Ensure all related files are archived both hard copies and soft files
- Check labelling compliance and identify corrective action with operation team
- Maintain the validity of company licenses by handling renewal of license
- Monitor the regulatory changes and consider the implications to business
- Create new RA templates related to regulatory compliance and usage limit and labelling, MSDS, and Health Certificate
- Monitor pending jobs and follow up to ensure that all tasks meet KPIs
- Communicate with internal and external parties to ensure all related action plans are met
- Train various functions including operation, supply chain, procurement, customer service, and distributor on regulatory requirements
Knowledge, Skills, and Requirements:
- Bachelor’s degree or Master degree in any fields
- Minimum 2-5 years related experience
- Experience in Thai FDA work is a plus
- Good command in English
- Familiar with food related knowledge is a plus
- Typing skill: English; at least 40 words/minutes, Thai; at least 30 words/minutes
- Proficient in Lotus Notes, Microsoft Words, Excel and PowerPoint